Sequenom Laboratories Expands International Noninvasive Prenatal Testing
Services To Broader Population With VisibiliT™ Test
New Data Supporting the Clinical Validity of Sequenom Laboratories'
Noninvasive Prenatal Tests Presented at the 18th International Conference on
Prenatal Diagnosis and Therapy
PR Newswire
SAN DIEGO, July 21, 2014
SAN DIEGO, July 21, 2014 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life
sciences company providing innovative genetic analysis solutions, today
announced that its wholly owned subsidiary, Sequenom Laboratories, will soon
launch the VisibiliT™ laboratory-developed test in international markets. The
VisibiliT test utilizes maternal age, fetal fraction and the relative amount
of chromosomal material for chromosomes 21 and 18 to generate a highly
accurate, personalized risk score. The VisibiliT test is for pregnant women
who want information about common fetal trisomies (Down syndrome and Edwards
syndrome), have a single gestation pregnancy, and whose pregnancies are
considered to be at average risk. The test can also report fetal gender. With
the VisibiliT test, Sequenom Laboratories fulfills its goal to expand its
noninvasive prenatal testing (NIPT) menu with the development of a low-cost
test by year-end to facilitate international access.
"This is an important development because it makes an excellent test much more
affordable and accessible to a wider spectrum of pregnant women throughout the
world," said Professor Kypros Nicolaides, M.D., director of the Fetal Medicine
Foundation and the Harris Birthright Research Centre for Fetal Medicine at
King's College Hospital in London.
Performance of the VisibiliT test was determined by a clinical evaluation
study of over 1,000 samples, and demonstrated a greater than 99% sensitivity
and specificity for trisomies 21 and 18. A poster entitled, 'Application of
risk-score analysis to low-coverage whole genome sequencing data for the
noninvasive detection of trisomy 21 and trisomy 18,' will be presented at the
18^th International Conference on Prenatal Diagnosis and Therapy(ISPD) taking
place July 20-23 in Brisbane, Australia.
Building a global portfolio of laboratory-developed tests for noninvasive
prenatal assessment
Sequenom Laboratories is the first test service provider to offer two distinct
NIPT options—MaterniT21™ PLUS and VisibiliT—enabling greater testing access
and flexibility for providers and patients.
"The launch of the VisibiliT test is an important achievement for the company,
as we are expanding our noninvasive prenatal testing menu to provide
additional choices to better serve the broader prenatal testing community,"
said William Welch, Chief Executive Officer of Sequenom, Inc. "We are
committed to innovating and building upon our market-leading NIPT services and
solutions as we continue to provide valuable information to health care
professionals and their patients around the world."
The VisibiliT test will be available to international markets beginning in
August. Sequenom Laboratories will continue ongoing discussions with payors in
the U.S. and is prepared to offer the test in the U.S. as insurance coverage
develops.
The technology at the forefront of prenatal testing
Sequenom Laboratories first pioneered the use of NIPT in 2011, with the
introduction of the MaterniT21 PLUS laboratory-developed test that's benefited
more than 250,000 pregnant women worldwide. Because of this advance, thousands
of pregnant women have avoided potentially unnecessary invasive procedures
while still gaining critical genetic information about the health of their
pregnancies. The VisibiliT test maintains the same Sequenom Laboratories'
commitment to quality and accuracy that's featured in the MaterniT21 PLUS
test.
Using a maternal blood sample, the VisibiliT and MaterniT21 PLUS tests analyze
chromosomal material in cell-free fetal DNA ofpregnant women. The VisibiliT
test reports a risk score for common fetal chromosomal abnormalities,
specifically trisomies 21 and 18, as well as fetal gender. The MaterniT21 PLUS
test, by contrast, reports both common and rare fetal chromosomal
abnormalities—from trisomies 21, 18 and 13 to fetal sex aneuploidies,
trisomies 16, 22, fetal gender and select microdeletions.
Both tests were developed, validated and are performed exclusively by Sequenom
Laboratories. Test results are provided to the ordering health care provider.
Sequenom Laboratories Presentations at ISPD
Tuesday, July 22, 2014, Session 6: Screening for aneuploidy / NIPT
o11:06-11:16 a.m. – NIPT 2.0: Identification of 22q microdeletions by
noninvasive prenatal testing; Presenter: Juan-Sebastian Saldivar
o11:39 – 11:45 a.m. – Genome wide analysis of sub-chromosomal copy number
variations using NIPT in over 4500 patients; Presenter: Dirk van den Boom
Sequenom Scientific Posters at ISPD
oCharacterization and targeted isolation of circulating cell-free DNA for
the noninvasive prenatal MaterniT21™ PLUS LDT
oNoninvasive detection of a balanced fetal translocation from maternal
plasma
oDetection of fetal subchromosomal abnormalities by sequencing circulating
cell-free DNA from maternal plasma
oFactors affecting levels of circulating cell-free fetal DNA in maternal
plasma and their implications for noninvasive prenatal testing
oEvaluation of targeted methodologies for the noninvasive detection of
fetal aneuploidies
oPrenatal detection of fetal aneuploidy on the Ion Torrent proton platform
oApplication of risk score analysis to low-coverage whole genome sequencing
data for the noninvasive detection of trisomy 21 and trisomy 18
About Sequenom
Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to
improving healthcare through revolutionary genomic and genetic analysis
solutions. Sequenom develops innovative technology, products and diagnostic
tests that target and serve molecular diagnostic markets. Website:
www.sequenom.com.
About Sequenom Laboratories
Sequenom Laboratories, a CAP accredited and CLIA-certified molecular
diagnostics laboratory, has developed a broad range of laboratory tests, with
a focus on prenatal and ophthalmological diseases and conditions. Branded
under the name HerediT™, MaterniT21™ PLUS, RetnaGene™, SensiGene™ and
VisibiliT™, these molecular genetic laboratory-developed tests provide early
patient management information for obstetricians, geneticists, maternal fetal
medicine specialists and ophthalmologists. Sequenom Laboratories is changing
the landscape in genetic disorder diagnostics using proprietary cutting edge
technologies.
SEQUENOM®, HerediT™, MaterniT21™ PLUS, RetnaGene™, SensiGene™ and VisibiliT™,
are trademarks of Sequenom, Inc. All other trademarks and service marks are
the property of their respective owners.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth
in this press release, including statements regarding Sequenom's expected
launch and availability in August of Sequenom Laboratories' VisibiliT test,
the impact and benefits of the test including affordability and accessibility
to a wider spectrum of pregnant women throughout the world, Sequenom's
commitment to innovating and building upon its market leading NIPT services
and solutions and its ability to continue to provide valuable information to
health care professionals and their patients, and Sequenom Laboratories' plans
to continue ongoing discussions with payors in the U.S. and its preparation to
offer the test in the U.S. as insurance coverage develops, Sequenom's
commitment to improving healthcare through revolutionary genomic and genetic
analysis solutions, and Sequenom Laboratories' changing the landscape in
genetic disorder diagnostics, are forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially, including
the risks and uncertainties associated with Sequenom's ability to develop and
commercialize new technologies and products, particularly new technologies
such as prenatal and other diagnostics and laboratory developed tests such as
the VisibiliT test, Sequenom's ability to manage its existing cash resources
or raise additional cash resources, competition, intellectual property
protection and intellectual property rights of others, government regulation
particularly with respect to diagnostic products and laboratory developed
tests, obtaining or maintaining regulatory approvals, ongoing patent
litigation, and other risks detailed from time to time in Sequenom, Inc.'s
most recent Quarterly and Annual Reports on Securities and Exchange Commission
Forms 10-Q and 10-K, respectively, and other documents subsequently filed with
or furnished to the Securities and Exchange Commission. These forward-looking
statements are based on current information that may change and you are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date of this press release. All forward-looking
statements are qualified in their entirety by this cautionary statement, and
Sequenom undertakes no obligation to revise or update any forward-looking
statement to reflect events or circumstances after the issuance of this press
release.
SEQUENOM logo.
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SOURCE Sequenom, Inc.
Website: http://www.sequenom.com
Contact: Carolyn Beaver, Chief Financial Officer, Sequenom, Inc.,
858-202-9028, investorrelations@sequenom.com; or Rachel Kennedy, Media
Contact, Chandler Chicco Agency, 858-449-9575,
rkennedy@chandlerchiccocompanies.com